FDA Inspection
Tri State Agri Services, LlcTri State Agri Services, Llc – FDA Inspection, Mar 1, 2012
Record Details
This FDA Inspection record concerns Tri State Agri Services, Llc, with an inspection on March 1, 2012, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Tri State Agri Services, Llc
- Inspection Date
- March 1, 2012
- Product Type
- Veterinary
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ID · 2dc17193-7919-413b-b49f-47e87d7e8cb8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 770517
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
14- 21 CFR 225.102(b)(1)Preparation of Master Record File
- 21 CFR 225.42(b)(3)Identification and storage of bulk drugs
- 21 CFR 225.30(b)(2)Equipment maintenance & cleanliness
- 21 CFR 225.58(d)Assay results out of specification
- 21 CFR 225.58(b)(1)First batch assay
- 21 CFR 225.58(b)(1)Three assays per year
- 21 CFR 225.102(b)(2)Elements of production record(s)
- 21 CFR 225.80(b)(2)Maintaining proofread label
- 21 CFR 225.65(b)(3)Sequential production
- 21 CFR 225.102(b)(4)Daily review of production records
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